The following data is part of a premarket notification filed by Xsirius Medical, Inc. with the FDA for Novacyte-u.
| Device ID | K862665 |
| 510k Number | K862665 |
| Device Name: | NOVACYTE-U |
| Classification | Container, Specimen Mailer And Storage, Sterile |
| Applicant | XSIRIUS MEDICAL, INC. PENINSULA POINTE SUITE 260 27520 HAWTHORNE BLVD. Rolling Hills Estates, CA 90274 |
| Contact | Eric Lietz |
| Correspondent | Eric Lietz XSIRIUS MEDICAL, INC. PENINSULA POINTE SUITE 260 27520 HAWTHORNE BLVD. Rolling Hills Estates, CA 90274 |
| Product Code | KDT |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-09-04 |